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Mid-term Performance of the CryoValve SG Human Decellularized Pulmonary Valve in 342 Patients Compared to the Conventional CryoValve
J. W. Brown*1, R. C. Elkins*2, D. R. Clarke*3, J. S. Tweddell*4, C. B. Huddleston*5, J. R. Doty*6, J. W. Fehrenbacher*7. 1Indiana University School of Medicine, Indianapolis, IN, 2University of Oklahoma Health Science Center, Oklahoma City, OK, 3The Children's Hospital Denver, Denver, CO, 4Children's Hospital of Wisconsin, Milwaukee, WI, 5St. Louis Children's Hospital, St. Louis, MO, 6Latter Day Saints Hospital, Salt Lake City, UT, 7Methodist Hospital of Indiana, Indianapolis, IN,
Objective: The objective of this study was evaluation of the mid-term clinical outcome of patients receiving CryoValve SG decellularized pulmonary valves (SGPV). The results were compared to those of patients receiving the conventionally processed pulmonary CryoValve (CV).
Methods: All patients having a Ross procedure or other right ventricular outflow tract (RVOT) reconstruction using SGPV pulmonary valves at seven institutions (2/2000 to 11/2005) were assessed retrospectively and compared to patients treated using the CV. The SGPV group included 193 Ross patients (mean age 30.7 years, 73% adult (>18 years), 27% pediatric and 149 RVOT patients (mean age 15.0 years, 72% adult, 28% pediatric). SGPV data were compared to data from 1,246 CV implants (1985-2006) used for Ross procedures (665) or RVOT reconstructions (581). CryoValve data was limited to a similar follow-up duration. Demographic and perioperative data, recent clinical follow-up and hemodynamic function data (peak or mean transvalvular gradient and valvular insufficiency at pre-op, discharge, and at least 1 year post-op) based on echocardiography were collected. Adverse events (mortality, valve-related death or explant, reoperation, endocarditis, thrombosis, thromboembolism, bleeding, and non-structural dysfunction) were identified and assessed using Kaplan-Meier methodology. Structural valve deterioration (SVD) was evaluated using presence of significant obstruction (peak ≥40 mmHg, mean ≥30 mmHg) or regurgitation (≥moderately severe) or occurrence of valve related adverse events.
Results: Follow-up of the SGPV recipients was current for 95% of the Ross patients, (819 patient-years), and 92% of the RVOT patients (475 patient-years). Hemodynamic data ≥1 year was available for 153 Ross patients (79%) at mean follow-up of 4.7 years (range 1-6.6) and 112 RVOT patients (75%) at mean follow-up of 3.86 years (range 1-6.7). Patient survival was significantly improved in the SGPV patients undergoing RVOT reconstruction. Kaplan-Meier results showed no significant differences in other adverse events between SGPV and CV patients. Peak gradients at last follow-up (≥1 year) did not differ between the SGPV and CV patients, but normal valve function as indicated by a regurgitation grade of trivial or less was significantly more common in the SGPV groups. Overall cumulative occurrence of SVD was not different between the two valve types in the Ross procedure patients, but in RVOT reconstruction occurrence of SVD was significantly less common in the SGPV patients (Table 1).| Table 1. Kaplan-Meier results for major event categories and valve functional outcomes in SGPV and CV patients undergoing a Ross procedure or RVOT reconstruction | | | Ross Procedure | RVOT Reconstruction | | | CryoValve SG | CryoValve | p value | CryoValve SG | CryoValve | p value | | Freedom from events at 5 years | Mortality | 97% | 95% | NS | 92% | 84% | 0.010 | | Valve related death or explant | 97% | 95% | NS | 93% | 89% | NS | | Endocarditis | 100% | 99% | NS | 98% | 100% | NS | | Reoperation | 95% | 95% | NS | 93% | 90% | NS | | Valve function at last follow up | Mean peak gradient (mmHg) | 19.0 ± 17 | 21.8 ± 17 | NS | 22.9 ± 17 | 22.2 ± 15 | NS | | Regurgitation trivial or less | 67% | 51% | 0.006 | 48% | 30% | 0.002 | | SVD | Patients free from SVD (%) | 79% | 78% | NS | 71% | 55% | 0.004 |
NS = not significant
Additional sub-group analysis revealed a significant decrease in peak gradient at last follow-up among the adult Ross patients. Peak gradient in the adult Ross SGPV patients averaged 15.8 mmHg while that of the CV patients was 19.9 (p=0.024).
Conclusions: The SGPV when used for the Ross operation or RVOT reconstruction has acceptable mid-term clinical outcomes and favorably compares with CV. Significantly better function observed in the SGPV population could signify improved long-term outcomes.
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